FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
K Number: K981737
·
Decision Dec 9, 1998
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
227
Applicant Total
26
Review Days
205
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Basic Information
- Device Name
- K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
- K Number
- K981737
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.5310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Katecho, Inc.
- Date Received
- May 18, 1998
- Decision Date
- December 9, 1998
- Product Code
- MKJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | FDA class 3 | Cardiovascular |
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Other Clearances by Katecho, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012404 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Oct 12, 2001 | Substantially Equivalent |
| K010543 | KM-30 TENS ELECTRODE | May 23, 2001 | Substantially Equivalent |
| K003228 | K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A | Dec 14, 2000 | Substantially Equivalent |
| K002806 | K-DEFIB/PACE, MODEL KDP-60A | Nov 21, 2000 | Substantially Equivalent |
| K000870 | KM-10 TENS ELECTRODE | Nov 7, 2000 | Substantially Equivalent |
| K993745 | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 | Feb 3, 2000 | Substantially Equivalent |
| K991007 | K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 | Aug 23, 1999 | Substantially Equivalent |
| K954504 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Nov 17, 1995 | Substantially Equivalent |
| K934692 | K-DEFIB/PACE PEDIATRIC ELECTRODE | Jan 24, 1995 | Substantially Equivalent |
| K940801 | K-KLIP | Aug 3, 1994 | Substantially Equivalent |